Children myopia control prognosis evaluation device and evaluation method based on choroid parameter detection

Abstract

The invention relates to a children myopia control prognosis evaluation device and evaluation method based on choroidal parameter detection, which are used for predicting the myopia control effect by taking the change of choroidal parameters within one month after the myopia control management of children and teenagers as a biological index for predicting the myopia control effect, so as to predict the myopia control management effect of the children and teenagers. The defect that prognosis evaluation of existing children and teenager myopia control management needs to track follow-up visit records for a long time is overcome, clinicians can be helped to guide myopia individuals to adjust appropriate control measures in time so as to effectively delay progression of the myopia individuals, and the method has important significance on management strategies of comprehensive prevention and control of children and teenager myopia.

Description

Technical Field

[0001] The present invention relates to the technical field of myopia, and particularly relates to a device and method for evaluating the prognosis of children's myopia control based on choroidal parameter detection. Background Art

[0002] Myopia, as a worldwide public health problem, has attracted more and more attention. Especially in East Asian and Southeast Asian countries such as China, South Korea, and Singapore, the myopia rate among high school students is as high as 80%, and even more than 10% of myopia patients are highly myopic. The increase in the degree of myopia will lead to higher-risk fundus complications and even blindness. Therefore, effective myopia prevention and control has become a difficult problem that we urgently need to solve.

[0003] In recent years, in order to explore the occurrence and development mechanism of myopia, many scholars have focused their research hotspots on the choroid. The choroid may regulate the extracellular matrix remodeling of the sclera, and by transmitting retinal source signals to the sclera, promote scleral remodeling, causing changes in axial length and refractive power of the eye. Then, as one of the currently recognized optical measures that can effectively control myopia progression - orthokeratology, can it predict the effect of myopia control through changes in the choroid? Orthokeratology (ortho-k) is one of the most widely used optical interventions for myopia control. It may reshape the corneal morphology and cause changes in the optical signals received by the retina, thereby achieving an annual delay in axial elongation of 32% to 55%. However, the mechanism behind this process is not yet clear. However, in clinical applications, about 27% of children receiving orthokeratology treatment have at least 1.00D of myopia progression and a 0.40 mm axial elongation in about 1 year. Since the evaluation of myopia control effect usually takes about 1 year, and the sensitive period of children's myopia development mainly focuses on the school age stage, this 1-year evaluation time window will hinder timely and effective myopia control, thus inevitably increasing the risk of myopia progression.

[0004] Numerous evidences indicate that changes in choroidal thickness can be used as an early prediction index for vision signal-driven eye growth and myopia development. During the formation of experimental myopia in animals, the choroidal thickness will become thinner; while when myopic defocus is applied to animals or the stimuli causing myopia are removed, the choroidal thickness will increase. Consistent with the choroidal thickness, choroidal blood flow also shows a two-way response to visual stimuli, and this change may act by reducing scleral hypoxia and affecting scleral remodeling. Recent studies on myopia animal models also show that the myopia inhibitory effects of several myopia control measures (atropine, apomorphine, and bright light) are related to the improvement of choroidal blood flow. These studies suggest that choroidal blood flow may be one of the mechanisms by which orthokeratology delays myopia. Summary of the Invention

[0005] To solve the technical defects existing in the prior art, the present invention provides a device and method for evaluating the prognosis of myopia control in children based on choroidal parameter detection. By combining an optical coherence tomography (OCT) system, a detailed evaluation of the choroidal structure and choroidal blood perfusion is performed, and the correlation between the choroidal changes after 1 month of wearing a corneal reshaping lens and the axial length growth in 1 year is obtained, thereby guiding clinicians to evaluate and select appropriate personalized myopia control measures, effectively and safely controlling the progression of myopia in children and adolescents, which is of great significance to the management strategy of myopia control by corneal reshaping.

[0006] The technical solution adopted by the present invention is: a device for evaluating the prognosis of myopia control in children based on choroidal parameter detection, including A parameter input module: input the choroidal parameters required for the myopia control prognosis evaluation model in children and transmit them to the myopia control prognosis evaluation model in children; An analysis module: including a myopia control prognosis evaluation model in children. The analysis module inputs the choroidal parameters into the myopia control prognosis evaluation model in children to obtain results and draw charts; A result output module: based on the results and charts obtained from the myopia control prognosis evaluation model in children, obtain the myopia control prognosis effect in children and output a report conclusion.

[0007] Children in this application generally refer to children and adolescents under 18 years old.

[0008] The choroidal parameters include one or several of the choroidal vascular index (CVI_baseline) before myopia control, the subfoveal choroidal thickness (SFCT_change) after 1 month of myopia control, and the change amount of the choroidal vascular lumen area (LA_change) within a 6 mm range in the macular area.

[0009] The choroidal parameters also include age (age) and gender (sex).

[0010] The regression equation of the myopia control prognosis evaluation model in children is Logit(P)= CVI_baseline * 0.4566 + SFCT_change * 0.4375 - sex * 1.4684 + age * 0.5691 - 33.4310, where in the gender option, 0 is assigned to females; 1 is assigned to males.

[0011] The regression equation of the described pediatric myopia control prognosis evaluation model is Logit(P) = CVI_baseline * 0.4531 + LA_change * 0.1301 - sex * 1.5146 + age * 0.6499 - 33.9012. In the gender option, the value assigned to females is 0; the value assigned to males is 1.

[0012] The described pediatric myopia control includes myopia control management including drug intervention, corrective surgery, and / or orthokeratology.

[0013] The described pediatric myopia control prognosis is the prognosis evaluation within one year after receiving myopia control management.

[0014] The described chart is a nomogram.

[0015] The described device further includes an optical coherence tomography (OCT) and an OCT angiography module, and the optical coherence tomography (OCT) and the OCT angiography module output the required choroidal parameters.

[0016] A method for evaluating the prognosis of pediatric myopia control based on choroidal parameter detection includes the following steps: (1) Obtain the required choroidal parameters of individuals undergoing myopia control including orthokeratology before and one month after control. The choroidal parameters are obtained by an optical coherence tomography (OCT) and an OCT blood flow imaging module; (2) Evaluate the relationship between the choroidal thickness and / or the change in the choroidal vascular lumen area one month after receiving pediatric myopia control management and the one-year prognosis based on the obtained choroidal parameters, and draw a chart based on the change in the choroidal thickness and the choroidal vascular lumen area one month after receiving pediatric myopia control management; (3) Obtain the prognosis evaluation result of one-year pediatric myopia control management based on the evaluation and the chart information.

[0017] The described choroidal parameters include one or several of the choroidal vascular index (CVI_baseline) before myopia control, the subfoveal choroidal thickness (SFCT_change) one month after myopia control, and the change in the choroidal vascular lumen area (LA_change) within a 6-mm range in the macular area.

[0018] In the step (2), the regression equation of the model for the prognosis evaluation of children's myopia control is Logit(P) = CVI_baseline * 0.4566 + SFCT_change * 0.4375 - sex * 1.4684 + age * 0.5691 - 33.4310. In the gender option, the value assigned to females is 0; the value assigned to males is 1.

[0019] In the step (2), the regression equation of the model for the prognosis evaluation of children's myopia control is: The regression equation of the model for the prognosis evaluation of children's myopia control is Logit(P) = CVI_baseline * 0.4531 + LA_change * 0.1301 - sex * 1.5146 + age * 0.6499 - 33.9012. In the gender option, the value assigned to females is 0; the value assigned to males is 1.

[0020] A computer-readable storage medium, the computer-readable storage medium includes a stored computer program; when the computer program runs, it controls the computer-readable storage medium to implement the method for the prognosis evaluation of children's myopia control.

[0021] The beneficial effects of the present invention are: The present invention provides a device and method for the prognosis evaluation of children's myopia control based on choroidal parameter detection. By using the changes in choroidal parameters one month after children's myopia control management as a biological indicator to predict the effect of myopia control, it solves the defect that the prognosis of the existing children's myopia control management requires long-term follow-up records, thereby guiding clinicians to evaluate and select appropriate personalized myopia control measures, effectively and safely controlling the progression of myopia in children and adolescents, which is of great significance to the management strategy of myopia control. Description of the Drawings

[0022] Figure 1 It is a ROC graph of a prediction model for one-year orthokeratology to distinguish slow and rapid axial length growth; wherein (A) using choroidal biomarkers alone; (B) baseline CVI plus LA change, baseline age and gender; (C) baseline CVI and SFCT change, baseline age and gender; Model 1: baseline CVI; Model 2: LA change; Model 3: SFCT change; Model 4: baseline CVI + LA change; Model 5: baseline CVI + LA change + age + gender; Model 6: baseline CVI + SFCT change; Model 7: baseline CVI + SFCT change + age + gender.

[0023] Figure 2 It is a nomogram including baseline CVI and SFCT change to predict the possibility of slow axial length growth.

[0024] Figure 3 For the changes in visual acuity and anterior corneal surface curvature over time in the orthokeratology lens group (OK lens group) and the single-vision frame glasses group (frame group); among them, A. Changes in visual acuity over time in the OK lens group and the frame group; B. Changes in FK and SK of the anterior corneal surface over time in the OK lens group and the frame group.

[0025] Figure 4 For the changes in axial length and anterior chamber depth over time in the orthokeratology lens group (OK lens group) and the single-vision frame glasses group (frame group); A: Changes in axial length over time; B: Changes in anterior chamber depth over time.

[0026] Figure 5 For the difference in choroidal thickness over time between the orthokeratology lens group and the single-vision frame glasses group.

[0027] Figure 6 For the difference in blood flow density of the choroidal capillary layer over time between the orthokeratology lens group and the single-vision frame glasses group.

[0028] Figure 7 For the difference in the proportion of non-perfused signal area in the choroidal capillary layer over time between the orthokeratology lens group and the single-vision frame glasses group.

[0029] Figure 8 For the effect of choroidal thickness changes in each region on axial length changes in the orthokeratology lens group (1-month follow-up).

[0030] Figure 9 For the effect of choroidal thickness changes in each region on axial length changes (6-month follow-up).

[0031] Figure 10 For the effect of choroidal thickness changes in each region on axial length changes (12-month follow-up).

[0032] Figure 11 For the effect of blood flow density changes in the choroidal capillary layer on axial length changes in the orthokeratology lens group (1-month follow-up).

[0033] Figure 12 For the effect of blood flow density changes in the choroidal capillary layer on axial length changes (6-month follow-up).

[0034] Figure 13 For the effect of blood flow density changes in the choroidal capillary layer on axial length changes (12-month follow-up). Figure 14 For the effect of changes in the proportion of non-perfused signal area in the choroidal capillary layer on axial length changes in the orthokeratology lens group (1-month follow-up).

[0035] Figure 15The impact of the change in the proportion of the non-perfused signal area in the choroidal capillary layer on the change in axial length of the eye (6-month follow-up).

[0036] Figure 16 The impact of the change in the proportion of the non-perfused signal area in the choroidal capillary layer on the change in axial length of the eye (12-month follow-up) Detailed implementation manners The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0037] Embodiment 1 Research subjects Subjects were continuously recruited and screened from August 2020 to September 2021, and children willing to wear orthokeratology lenses were followed up for 1 year. The inclusion criteria were as follows: aged between 8 and 12 years old, corrected visual acuity of 20 / 20 or higher, spherical equivalent refraction (SER) between -5.00D and -0.75D, astigmatism not greater than 2.00D, and the interocular difference of SER less than or equal to 1.50D. Excluded subjects included those with active inflammation or ocular surface diseases, strabismus, and a history of using or currently using myopia control measures (such as orthokeratology lenses, multifocal soft contact lenses, atropine eye drops).

[0038] Examination contents Ocular examinations were performed before orthokeratology lens fitting, and the same examinations were carried out on the day, one week, one month, three months, six months, nine months, and twelve months after wearing orthokeratology lenses. At each visit, uncorrected visual acuity, subjective refraction (if uncorrected visual acuity was lower than 20 / 25), and corneal topography (Medmont E-300, Australia) were evaluated. In addition, slit lamp examinations were also performed to check the orthokeratology lens fitting and related complications. The axial length (AL) was measured using IOL-Master 700 (Carl Zeiss Meditec AG, Germany) before starting to wear and at 1 month, 6 months, and 12 months of wearing, and choroidal parameters were measured using swept-source OCT / OCT angiography (SS-OCT / OCTA). All examinations were carried out during the same time period (morning or afternoon) at each visit to minimize diurnal variations. All participants were advised to wear orthokeratology lenses at least 8 hours every night.

[0039] The final analysis included participants with complete data at the start of orthokeratology lens wear and at 1 month and 1 year later. Due to the high symmetry between the two eyes of the same individual, we used the data from the right eye for analysis. To minimize the influence of the follow-up time window, the annual axial length growth was adjusted according to the actual number of days of orthokeratology lens wear.

[0040] Statistical analysis was performed using SPSS Statistics 26.0 (IBM, Armonk, NY, USA) and R version 4.2.0 (R Foundation for Statistical Computing). The normality of the data was checked by the Shapiro-Wilk test. The data were described using the mean and standard deviation or the number and percentage, and the t-test, Mann-Whitney test or chi-square test was used for comparison when appropriate. Pearson or Spearman correlation analysis was used to calculate the degree and statistical significance of the association between variables. A linear regression model was used to evaluate the factors associated with the 1-year axial length growth. Factors with a P-value < 0.05 in the univariate analysis were added to the multivariate model, in which age and gender were also entered as covariates into the model.

[0041] To evaluate the predictive value of choroidal biomarkers, the receiver operating characteristic curve (ROC) with the area under the curve (AUC) was used to quantify the performance of the model in predicting the groups with rapid or slow axial length growth (the definition of rapid or slow axial length growth was divided according to the median annual axial length growth of the study subjects). The Delong test was used to evaluate the differences in AUC between different prediction models. In addition, the integrated discrimination improvement index (IDI) based on the Z-test was used to evaluate the improvement in the model prediction accuracy after adding other predictors to the previous model. According to the most valuable prediction model, a candidate nomogram model with good predictive performance was finally constructed. To visualize the results, every 10 μm change in SFCT and every 0.01 mm 2 change in LA, SA and TCA in the model were defined as 1 change unit.

[0042] Results After 1 month of orthokeratology lens wear in myopic children, the choroid showed vascular dilation and increased thickness. As shown in Table 1, after dividing into two subgroups of rapid progressors and slow progressors based on the median annual axial length growth (0.16 mm) of 50 children, it was found that the subfoveal choroidal thickness (SFCT) and the lumen area (LA) in the slow progressor group increased more than those in the rapid progressor group.

[0043] Table 1. Differences in choroidal changes at 1 month between the rapid progressor subgroup and the slow progressor subgroup 1-Month Change Total (n = 50) Progression ≤ 0.16mm (n = 25) Progression > 0.16mm (n = 25) P value LA (mm2) 0.03±0.07 0.06±0.08 0.01±0.06 0.012 SA (mm2) 0.02±0.05 0.04±0.03 0.01±0.05 0.015 TCA (mm2) 0.06±0.11 0.10±0.09 0.01±0.10 0.005 SFCT (μm) 10.62±19.98 17.33±17.55 3.91±20.32 0.023 CVI (%) -0.18±1.90 -0.27±2.00 -0.10±1.82 0.559 CcFD (%) 0.19±1.44 -0.10±1.55 0.47±1.30 0.185 LA, luminal area; SA, stromal area; TCA, total choroidal area; SFCT, sub-foveal choroidal thickness; CVI, choroidal vascularity index; CcFD, choriocapillaris flow deficits. P value determined by covariance analysis. Bold font indicates statistical significance. As Figure 1 shown, prediction models (Logit(P)= CVI_baseline * 0.4531 + LA_change * 0.1301 - sex * 1.5146 + age * 0.6499 - 33.9012) and (Logit(P)= CVI_baseline * 0.4566 + SFCT_change * 0.4375 - sex * 1.4684 + age * 0.5691 - 33.4310) were constructed based on the 1-month changes in choroidal vascularity index (baseline CVI), luminal area (LAchange), or sub-foveal choroidal thickness (SFCT change) before wearing glasses, as well as age and gender. ROC analysis showed that the areas under the curve (AUC) based on LA_change and SFCT_change were 0.883 and 0.872, respectively, which could well predict the one-year axial length growth of children wearing orthokeratology lenses.

[0044] Considering that the measurement of SFCT is more convenient and standardized than LA measurement in clinical practice, a prediction model (Logit(P)= CVI_baseline * 0.4566 + SFCT_change * 0.4375 - sex * 1.4684 + age * 0.5691 - 33.4310) was constructed using baseline CVI, 1-month change in SFCT, age, and gender. A nomogram was drawn to facilitate clinicians in predicting the one-year control effect of children wearing orthokeratology lenses to guide clinical myopia prevention and control. As Figure 2As shown, the patient in the figure is a research example (shown in red). The patient is male, 8.6 years old. The baseline CVI is 60.55%, and the change in SFCT in one month is 27.96 μm. In the nomogram, the specific point (black dot) of each patient is located on each variable axis. The red line and dot are drawn upward to determine the score obtained for each variable; the sum of these points (122.15) is located on the total score axis, and a line is drawn downward to determine the probability (58%) of slow axial elongation (i.e., better prognosis control) after orthokeratology lens wear. CVI, choroidal vascular index; SFCT, subfoveal choroidal thickness; AL, axial length.

[0045] Example 2 To verify the effects of orthokeratology lens wear on choroidal thickness and choroidal blood flow in myopic children, through a one-year observation of myopic children wearing orthokeratology lenses and comparison with the single-vision frame glasses group, understand the changes and patterns of choroidal thickness and choroidal capillary layer blood flow after wearing orthokeratology lenses, analyze their correlation with axial length changes, and explore the potential value of choroidal thickness and choroidal capillary blood flow as predictors of the myopia control effect of orthokeratology lenses.

[0046] Complete the measurement of ocular parameters such as visual acuity, refractive power, corneal topography, and axial length. At the same time, use the Enhance HD line mode of Optovue RTvue OCT to measure choroidal thickness, and use the Angio Retina (3mm * 3mm) mode of Optovue RTvue OCT to measure the blood flow density of the choroidal capillary layer and the proportion of the non-perfused signal area (Flowvoids) in the choroidal capillary layer.

[0047] Research subjects This study included myopic children who visited the Optometry Clinic of the Eye Hospital Affiliated to Wenzhou Medical University from February 2018 to January 2020 and were willing to be fitted with orthokeratology lenses or single-vision frame glasses for myopia correction. The right eye was selected as the study eye. Since the recruited subjects were minors, both the subjects and their guardians signed a written informed consent form after full informed consent.

[0048] Research process Screen myopic children and adolescents in the outpatient clinic who are willing to correct myopia by wearing orthokeratology lenses or single-vision frame glasses and are willing to be followed up regularly, obtain informed consent, and obtain oral consent and sign the informed consent form in writing.

[0049] After enrollment, the subjects first completed naked eye visual acuity measurement and entry examination to understand eye position, eye movement and accommodation function. Then, the degree of refractive error was determined by computer optometry and subjective optometry in the non-ciliary muscle paralysis state. After that, a slit lamp examination was performed to understand the health of the eyes and the tear film. The eye health examination included the health of the eyelids, conjunctiva, cornea, anterior chamber, iris and lens. The tear film examination included the time after the tear film broke up and the height of the tear prism. Then, a non-contact tonometer was used to measure intraocular pressure. The flat curvature value (Flat K), steep curvature value (Steep K), astigmatism value and E value of the anterior corneal surface were measured by corneal topography. The axial length and anterior chamber depth were measured by IOLMaster. The corneal endothelial cell density, 6A cell ratio and CV value were measured by keratoscope. Color fundus photos were taken to confirm whether the fundus was normal. Combined with the above examination results and the interview, it was determined whether the subjects met the inclusion and exclusion criteria. Finally, the subjects and guardians were divided into the orthokeratology lens group and the single-vision frame glasses group according to their wishes.

[0050] The orthokeratology lens group selects the appropriate trial lenses based on the examination results, and performs fitting evaluation after 30 minutes of trial wearing. Fit evaluation includes dynamic and static fitting of lenses. Dynamic fitting includes lens positioning, mobility and optical zone coverage. Static fitting includes fluorescence fitting of base curve area, inversion curve area, positioning curve area and edge curve area. After determining the ideal trial lenses, optometry is performed, and finally the lens diameter, positioning curve, reduction and other parameters are determined to customize the lenses. The single-vision frame glasses group customizes the lenses after the subjective optometry degree is tried.

[0051] The subjects in both groups were required to wear lenses every day. The orthokeratology lens group required regular follow-up on the first day, first week, and first month after lens removal, and every 3 months thereafter. Daily follow-up required examination of naked eye visual acuity, slit lamp examination of eye health and tear film, lens fit and lens condition, intraocular pressure, corneal topography, axial length and anterior chamber depth. In addition to the baseline, choroidal thickness, choroidal capillary layer blood flow density, and the proportion of choroidal capillary layer non-perfusion signal area were also required to be examined at 1 month, 6 months, and 12 months. The single-vision frame glasses group required follow-up at 6 months and 12 months in addition to the baseline. The examination contents included naked eye visual acuity, slit lamp examination of eye health and tear film, lens condition, intraocular pressure, corneal topography, axial length and anterior chamber depth, choroidal thickness, choroidal capillary layer blood flow density, and the proportion of choroidal capillary layer non-perfusion signal area. All examinations were completed between 8:30 and 10:30 in the morning to reduce the impact of day and night fluctuations on the examination results.

[0052] Follow-up changes in ocular parameters After wearing orthokeratology lenses, the axial length of the eye was slightly shortened compared with the baseline, which was -0.02±0.01 ( P= 0.005), and then increased slowly at the 6 - month and 12 - month visits. There were statistically significant differences in the axial length change compared with the baseline at the 6 - month and 12 - month visits (6 - month: P <0.001; 12 - month: P <0.001); and the anterior chamber depth also decreased slightly compared with the baseline at the 1 - month visit, being - 0.05 ± 0.02 ( P = 0.038). After that, it basically remained stable. There were statistically significant differences in the anterior chamber depth change compared with the baseline at the 6 - month and 12 - month visits (6 - month: P <0.001; 12 - month: P <0.001); The anterior corneal surface FK and SK became significantly flatter at 1 month after wearing the lens and then basically remained stable; Based on the above - mentioned changes in corneal morphology, the uncorrected visual acuity improved significantly at the 1 - month visit, with the LogMAR visual acuity increasing from 1.00 to 0.00 and then tending to be stable, as shown in Figure 3 - 4 . In the single - vision frame glasses group, the axial length and anterior chamber depth both increased compared with the baseline at the 6 - month and 12 - month visits, and the differences were statistically significant (axial length: 6 - month: P <0.001; 12 - month: P <0.001; anterior chamber: 6 - month: P <0.001; 12 - month: P <0.001), while the uncorrected visual acuity decreased slightly during the visits, and the anterior corneal surface FK and SK remained stable during the visits, as shown in Figure 3 - 4 .

[0053] When comparing the orthokeratology group and the single - vision frame glasses group, there was no statistically significant difference in the change of axial length compared with the baseline at the 6 - month visit ( P = 0.064). There were statistically significant differences in the change of axial length compared with the baseline at the 12 - month visit and in the change of anterior chamber depth compared with the baseline at the 6 - month and 12 - month visits (axial length: 12 - month: P <0.001; anterior chamber: 6 - month: P = 0.01; 12 - month: P = 0.021). The growth of the axial length and anterior chamber depth in the orthokeratology group was slower than that in the single - vision frame glasses group, as shown in Figure 4 .

[0054] Follow - up changes in choroidal thickness, blood flow density in the choroidal capillary layer, and the proportion of non - perfusion signal area in the choroidal capillary layer Differences in choroidal thickness change over time between the orthokeratology group and the single - vision frame glasses group There were obvious regional differences in the choroidal thickness of both the orthokeratology group and the single - vision frame glasses group ( P <0.001). The choroid was thickest in the superior region, followed by the temporal region. The choroidal thickness in the central region was in the middle, then the inferior region, and the thinnest was in the nasal region, as shown inFigure 5 。There was a statistically significant interaction between time and group ( P <0.001). After wearing orthokeratology lenses for 1 month, the choroidal thickness increased significantly compared with the baseline. At the 6-month visit, it increased by 6.27 μm compared with the baseline, with a statistically significant difference ( P <0.001). At the 12-month visit, it increased by 4.64 μm compared with the baseline, with a statistically significant difference ( P =0.002). However, the single-vision spectacle lens group lacked data at the 1-month visit. Only the 6-month and 12-month visits were compared with the baseline. At the 6-month visit, the choroidal thickness increased by 0.26 μm compared with the baseline, without a statistically significant difference ( P =0.878). At the 12-month visit, it decreased by 4.01 μm compared with the baseline, with a statistically significant difference ( P =0.017). When comparing the two groups, at the 6-month visit, there was a between-group difference in the change of choroidal thickness compared with the baseline ( P =0.017); at the 12-month visit, there was a between-group difference in the change of choroidal thickness compared with the baseline ( P <0.001). Therefore, after wearing for one year, the choroidal thickness in the orthokeratology lens group increased, with the largest increase at 1 month, while the choroidal thickness in the single-vision spectacle lens group thinned, as shown in Figure 5 .

[0055] Differences in the blood flow density of the choroidal capillary layer over time between the orthokeratology lens group and the single-vision spectacle lens group There were significant regional differences in the blood flow density of the choroidal capillary layer in both the orthokeratology lens group and the single-vision spectacle lens group ( P <0.001), among which the blood flow density of the choroidal capillary layer in the central area was the largest. There was an interaction between time and group ( P =0.002), and there was also an interaction analysis between region and group ( P =0.006), as shown in Table 7-8 and Figure 5 . After wearing orthokeratology lenses for 1 month, the blood flow density of the choroidal capillary layer in all 5 regions increased significantly compared with the baseline. At the 6-month visit, it increased by 2.87% compared with the baseline, with a significant statistical difference ( P <0.001). At the 12-month visit, it increased by 1.56% compared with the baseline, with a significant statistical difference ( P <0.001). However, the single-vision spectacle lens group lacked data at the 1-month visit. Only the 6-month and 12-month visits were compared with the baseline. At the 6-month visit, the blood flow density of the choroidal capillary layer increased by 0.74% compared with the baseline, without a statistically significant difference ( P =0.162). At the 12-month visit, it increased by 1.46% compared with the baseline, with a statistically significant difference ( P =0.006). When comparing the two groups, at the 6-month visit, there was a between-group difference in the change of the blood flow density of the choroidal capillary layer compared with the baseline (P = 0.017); At the 12 - month visit, there was a significant difference between groups in the change of choroidal capillary layer blood flow density compared with the baseline ( P <0.001). Therefore, after one year of wearing, the blood flow density of the choroidal capillary layer increased in both the orthokeratology group and the single - vision spectacle group. The increase was the largest in the orthokeratology group in January, as shown in Figure 6 .

[0056] The difference in the proportion of the non - perfusion signal area in the choroidal capillary layer between the orthokeratology group and the single - vision spectacle group over time The proportion of the non - perfusion signal area in the choroidal capillary layer of both the orthokeratology group and the single - vision spectacle group showed significant regional differences ( P <0.001), among which the proportion of the non - perfusion signal area in the central choroidal capillary layer was the smallest. The interaction between region and group was statistically significant ( P <0.001). See Figure 7 . After wearing orthokeratology lenses for 1 month, the proportion of the non - perfusion signal area in the choroidal capillary layer decreased compared with the baseline in the other 4 regions except the central area. At the 6 - month and 12 - month visits, in the orthokeratology group, the proportion of the non - perfusion signal area in the choroidal capillary layer decreased slightly compared with the baseline in the other regions except the superior 0.6 - 2.5 mm area at the 6 - month visit, but there was no statistical difference. In the single - vision spectacle group, the proportion of the non - perfusion signal area in the choroidal capillary layer increased slightly compared with the baseline in the other regions except the C0.6 mm area at the 6 - month visit and the nasal 0.6 - 2.5 mm area at the 12 - month visit. See Figure 7 . During the follow - up, the blood flow density of the choroidal capillary layer increased in the orthokeratology group, and the proportion of the non - perfusion signal area in the choroidal capillary layer decreased slightly, showing a good complementary trend, while the single - vision spectacle group did not show a similar change trend. There was no difference in the proportion of the non - perfusion signal area in the choroidal capillary layer between the two groups ( P = 0.43), and there was no interaction between time and group ( P = 0.371).

[0057] The effect of choroidal thickness change on axial length change There was no difference in the linear regression coefficients between the orthokeratology group and the single - vision spectacle group at the 6 - month and 12 - month visits.

[0058] At the 1 - month visit, there was a statistically significant negative correlation between the changes in choroidal thickness and axial length in the central area and the nasal area (Central: β = - 0.00078, P = 0.009; Nasal 1.0 - 2.0 mm: β = - 0.00089, P = 0.007; Nasal 2.0 - 3.0 mm: β = - 0.00087, P= 0.02), and there was no linear relationship between the changes in choroidal thickness and axial length in the remaining regions ( P both > 0.05). At the 6-month visit, except for the superior region, there were statistically significant negative correlations between the changes in choroidal thickness and axial length in the central, inferior, nasal, and temporal regions (central: β = -0.00211, P < 0.001; inferior 1.0 - 2.0 mm: β = -0.0008, P = 0.015; inferior 2.0 - 3.0 mm: β = -0.00067, P = 0.047; nasal 1.0 - 2.0 mm: β = -0.00214, P < 0.001; nasal 2.0 - 3.0 mm: β = -0.00163, P < 0.001; temporal 1.0 - 2.0 mm: β = -0.00102, P = 0.008; temporal 2.0 - 3.0 mm: β = -0.0008, P = 0.023). At the 12-month visit, there were statistically significant negative correlations between the changes in choroidal thickness and axial length in all regions, as shown in Figure 8 - 10 . The more the choroidal thickness increased, the slower the axial length grew.

[0059] Effect of changes in blood flow density in the choroidal capillary layer on axial length changes There was no difference in the linear regression coefficients between the orthokeratology group and the single-vision frame glasses group at the 6-month and 12-month visits.

[0060] There was no linear relationship between the changes in blood flow density in the choroidal capillary layer and axial length at the 1-month and 12-month visits ( P both > 0.05). At the 6-month visit, except for the central region, there were statistically significant negative correlations between the changes in blood flow density in the choroidal capillary layer and axial length in the remaining regions (superior 0.6 - 2.5 mm: β = -0.00395, P = 0.003; inferior 0.6 - 2.5 mm: β = -0.00344, P = 0.011; nasal 0.6 - 2.5 mm: β = -0.00317, P = 0.022; temporal 0.6 - 2.5 mm: β = -0.00287, P = 0.027), as shown in Figure 11 - 13 . According to the 6-month visit results, the more the blood flow density in the choroidal capillary layer increased, the slower the axial length grew.

[0061] Effect of changes in the proportion of perfusion-free signal areas in the choroidal capillary layer on axial length changes There was no difference in the linear regression coefficients between the orthokeratology lens group and the single-vision frame glasses group during the June and December visits.

[0062] There was no linear relationship between the change in the proportion of the choroidal capillary layer with non-perfusion signal area and the change in axial length during the January visit ( P both > 0.05). During the June visit, there were statistically significant correlations between the change in the proportion of the choroidal capillary layer with non-perfusion signal area and the change in axial length in the central region, the superior 0.6 - 2.5 mm region, and the inferior 0.6 - 2.5 mm region (central: β = -0.1086, P p = 0.001; superior 0.6 - 2.5 mm: β = 0.01836, P p = 0.012; inferior 0.6 - 2.5 mm: β = 0.02203, P p = 0.037), and there was no linear relationship in the nasal and temporal regions ( P both > 0.05). During the December visit, there was a statistically significant positive correlation between the change in the proportion of the choroidal capillary layer with non-perfusion signal area and the change in axial length in the superior 0.6 - 2.5 mm region and the inferior 0.6 - 2.5 mm region (superior 0.6 - 2.5 mm: β = 0.0384, P p < 0.001; inferior 0.6 - 2.5 mm: β = 0.03485, P p = 0.04), and there was no linear relationship in the remaining regions ( P both > 0.05), as shown in Figure 14 - 16 . The more the proportion of the choroidal capillary layer with non-perfusion signal area increased, the faster the axial length increased.

[0063] Results: 1. A total of 91 subjects were included in this study, 61 wearing orthokeratology lenses and 30 wearing single-vision frame glasses. The median age in the orthokeratology lens group was 11 years, the male-to-female ratio was 29:32, the equivalent spherical lens degree was -3.48 ± 1.37 D, the axial length was 25.29 ± 0.98 mm, and the median best LogMAR corrected visual acuity was -0.10. The median age in the single-vision frame glasses group was 11 years, the male-to-female ratio was 17:13, the equivalent spherical lens degree was -2.92 ± 1.08 D, the axial length was 25.09 ± 0.62 mm, and the median best LogMAR corrected visual acuity was -0.10.

[0064] 2. When comparing the orthokeratology lens group and the single-vision frame glasses group, there was no statistical difference in the change in axial length from the baseline between the two groups during the June visit, and there were statistical differences in the change in axial length from the baseline during the December visit and the change in anterior chamber depth from the baseline during the June and December visits between the two groups (axial length: December: P p < 0.001; anterior chamber: June: P p = 0.01; December:P (= 0.021), the growth of axial length and anterior chamber depth in the orthokeratology group was slower than that in the single vision spectacle group.

[0065] 3. The choroidal thickness in both the orthokeratology group and the single vision spectacle group showed significant regional differences (<0.001), with the thickest choroid in the superior region and the thinnest in the nasal region. The interaction between time and group was statistically significant (<0.001). When comparing the two groups, there were statistically significant differences in the change of choroidal thickness compared with the baseline at the 6 - month and 12 - month visits (6 - month: P = 0.017; 12 - month: P <0.001). After one year of wearing, the choroidal thickness increased in the orthokeratology group and decreased in the single vision spectacle group. P = 0.017; 12 - month: P <0.001). After one year of wearing, the choroidal thickness increased in the orthokeratology group and decreased in the single vision spectacle group.

[0066] 4. The blood flow density of the choroidal capillary layer in both the orthokeratology group and the single vision spectacle group showed significant regional differences (<0.001), with the highest blood flow density in the central area. The interactions between time and group, and between region and group were statistically significant (<0.002; P <0.001), central area choroidal capillary layer blood flow density was the largest. The interactions between time and group, and between region and group were statistically significant (<0.002; P = 0.002; P = 0.006). When comparing the two groups, there were statistically significant differences in the change of blood flow density of the choroidal capillary layer compared with the baseline at the 6 - month and 12 - month visits (6 - month: P = 0.017; 12 - month: P <0.001). After one year of wearing, the blood flow density of the choroidal capillary layer increased in both the orthokeratology group and the single vision spectacle group.

[0067] 5. The proportion of the non - perfusion signal area in the choroidal capillary layer in both the orthokeratology group and the single vision spectacle group showed significant regional differences (<0.001), with the smallest proportion in the central area. The interaction between region and group was significantly statistically different (<0.001). There was no statistical difference between the two groups. P <0.001), central area choroidal capillary layer non - perfusion signal area proportion was the smallest. The interaction between region and group was significantly statistically different (<0.001). There was no statistical difference between the two groups. P <0.001). There was no statistical difference between the two groups.

[0068] 6. The change in choroidal thickness in each region was significantly negatively correlated with the change in axial length. The more the choroidal thickness increased, the slower the axial length growth.

[0069] 7. At the 6 - month visit, except for the central region, the change in blood flow density of the choroidal capillary layer in the other regions was significantly negatively correlated with the change in axial length. The more the blood flow density of the choroidal capillary layer increased, the slower the axial length growth.

[0070] 8. At the visits in June and December, the change in the proportion of the non-perfused signal area in the choroidal capillary layer in each region was positively correlated with the change in axial length in a statistically significant manner. The more the proportion of the non-perfused signal area in the choroidal capillary layer increased, the faster the axial length increased.

[0071] Conclusion: Compared with single-vision frame glasses, wearing orthokeratology lenses can effectively delay the growth of axial length and anterior chamber depth, while promoting the increase in choroidal thickness and blood flow density in the choroidal capillary layer, and there is no obvious change in the proportion of the non-perfused signal area in the choroidal capillary layer. Moreover, after wearing orthokeratology lenses, the more the blood flow density in the choroidal capillary layer increases, the less the proportion of the non-perfused signal area in the choroidal capillary layer increases, and the more the choroidal thickness increases, the slower the axial length grows. This study suggests that the changes in choroidal thickness and choroidal capillary layer blood flow after wearing orthokeratology lenses have the potential to become predictive indicators for the effect of orthokeratology lenses in delaying axial length growth and preventing and controlling myopia.

[0072] Dear technicians, please note that although the present invention has been described according to the above specific embodiments, the inventive concept of the present invention is not limited to this invention only. Any modification using the inventive concept of the present invention will be included in the protection scope of the patent right of this patent.

[0073] The above are only the preferred embodiments of the present invention. The protection scope of the present invention is not limited to the above embodiments only. All technical solutions falling within the inventive concept of the present invention belong to the protection scope of the present invention. It should be pointed out that for those of ordinary skill in the art, several improvements and refinements made without departing from the principle of the present invention should also be regarded as within the protection scope of the present invention.

Claims

1. A prognostic evaluation device for children's myopia control based on choroid parameter detection, characterized in that, including Parameter input module: Input the choroid parameters required for the pediatric myopia control prognosis evaluation model and transmit them to the pediatric myopia control prognosis evaluation model; Analysis module: including the pediatric myopia control prognosis evaluation model, and the analysis module inputs the choroid parameters into the pediatric myopia control prognosis evaluation model to obtain results and draw charts; Result output module: Based on the results and charts obtained from the pediatric myopia control prognosis evaluation model, obtain the pediatric myopia control prognosis effect and output the report conclusion.

2. The prognostic evaluation device for children's myopia control based on choroid parameter detection according to claim 1, wherein , the choroid parameters include one or several of the choroidal vascular index before myopia control (CVI_baseline), the subfoveal choroidal thickness (SFCT_change) one month after myopia control, and the change in the choroidal vascular lumen area (LA_change) within a 6mm range in the macular area.

3. The prognostic evaluation device for children's myopia control based on choroid parameter detection according to claim 1, wherein , the choroid parameters also include age (age) and gender (sex).

4. A prognostic evaluation device for children's myopia control based on choroidal parameter detection according to any one of claims 1-3, characterized in that , the regression equation of the pediatric myopia control prognosis evaluation model is Logit(P) = CVI_baseline * 0.4566 + SFCT_change * 0.4375 - sex * 1.4684 + age * 0.5691 - 33.4310, where in the gender option, female is assigned 0; male is assigned 1.

5. A prognostic evaluation device for children's myopia control based on choroid parameter detection according to any one of claims 1-3, characterized in that , the regression equation of the pediatric myopia control prognosis evaluation model is Logit(P) = CVI_baseline * 0.4531 + LA_change * 0.1301 - sex * 1.5146 + age * 0.6499 - 33.9012, where in the gender option, female is assigned 0; male is assigned 1.

6. The prognostic evaluation device for children's myopia control based on choroid parameter detection according to claim 1, wherein The pediatric myopia control includes pediatric myopia control management including drug intervention, corrective surgery, and / or orthokeratology.

7. An apparatus for evaluating the prognosis of children's myopia control based on choroid parameter detection according to claim 1, wherein The pediatric myopia control prognosis is the prognosis evaluation within one year after receiving pediatric myopia control management.

8. The prognostic evaluation device for children's myopia control based on choroid parameter detection according to claim 1, characterized in that, The chart is a nomogram.

9. An apparatus for evaluating the prognosis of children's myopia control based on choroid parameter detection according to claim 1, characterized in that, The device also includes an optical coherence tomography (OCT) and OCT angiography module, and the optical coherence tomography (OCT) and OCT angiography module output the required choroid parameters.

10. A method for evaluating the prognosis of children's myopia control based on choroid parameter detection, characterized in that, including the following steps: (1) Obtain the required choroid parameters of individuals undergoing myopia control including orthokeratology before and one month after control, and the choroid parameters are obtained by optical coherence tomography (OCT) and OCT blood flow imaging module; (2) Evaluate the relationship between the change in choroidal thickness and / or choroidal vascular lumen area one month after receiving pediatric myopia control measures and the one-year prognosis based on the obtained choroid parameters, and draw a chart based on the change in choroidal thickness and choroidal vascular lumen area one month after receiving pediatric myopia control management; (3) Obtain the one-year prognosis evaluation result after receiving pediatric myopia control management based on the evaluation situation and chart information.

11. A method for evaluating the prognosis of children's myopia control based on choroid parameter detection according to claim 10, characterized in that , the choroidal parameters include one or several of the choroidal vascular index before myopia control (CVI_baseline), the subfoveal choroidal thickness (SFCT_change) 1 month after myopia control, and the change in the choroidal vascular lumen area (LA_change) within a 6-mm range in the macular area.

12. A method for evaluating the prognosis of children's myopia control based on choroid parameter detection according to claim 10, characterized in that, In the step (2), the regression equation of the model for predicting the prognosis of childhood myopia control is Logit(P) = CVI_baseline * 0.4566 + SFCT_change * 0.4375 - sex * 1.4684 + age * 0.5691 - 33.4310, where in the gender option, 0 is assigned to females and 1 is assigned to males.

13. A method for evaluating the prognosis of children's myopia control based on choroid parameter detection according to claim 10, characterized in that, In the step (2), the regression equation of the model for predicting the prognosis of childhood myopia control is: the regression equation of the model for predicting the prognosis of childhood myopia control is Logit(P) = CVI_baseline * 0.4531 + LA_change * 0.1301 - sex * 1.5146 + age * 0.6499 - 33.9012, where in the gender option, 0 is assigned to females and 1 is assigned to males.

14. A computer-readable storage medium, characterized in that, The computer-readable storage medium includes a stored computer program; when the computer program runs, it controls the computer-readable storage medium to implement the method described in claim 10.

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